May 8, 2012 at 1:24 PM by cdisc
After two days of training on SDTM, ODM, PRM and ADaM, the official kick off of the Interchange began on Wednesday, 18 April 2012. The program on Wednesday featured two opening plenary sessions followed by two parallel track sessions, the first of which focused on BRIDG and CDASH. I personally sat in on the BRIDG session, and had the opportunity to listen to presentations given by Sue Dubman of Genzyme, Isabelle Zegher of Perceptive Informatics, and Joerg Dillert of Oracle.
Sue Dubman, BRIDGing to Improve Connection with Patients and Providers: A Case Study Ms. Dubman, who is also a director on the CDISC Board, discussed the benefits of adopting BRIDG, incorporating the example of Genzyme’s RegistryNXT! Program, a web-based disease registry platform that consolidated existing Genzyme Lysosomal Storage Disorders (LSD) registries and other rare disease registries, with BRIDG as its underlying information model.
Ms. Dubman stressed that using BRIDG, a model driven by real-world experiences and use cases, should continuously change and expand. This process requires participation and contributions to BRIDG from an ever-increasing number of groups interested in contributing and collaborating towards its continuing development. “A common standard is a shared good that can benefit all,” she noted.
Genzyme used BRIDG v 3 when creating a data model for RegistryNXT!, incorporating BRIDG classes, entities and relationships as much as possible. When other entities, attributes and relationships needed for RegistryNXT! were found to be missing from BRIDG, they should be added; now Genzyme is working with the BRIDG Semantic Coordination Committee (SCC) to pull in those mappings into BRIDG through the form of extensions. Ms. Dubman emphasized that those quickest to adopt BRIDG will be those who are able to have the most significant impact on the direction and development of this model.
RegistryNXT! was a stellar development for Genzyme, and won an internal innovation award from Sanofi. (See…..link to CDISC press release) Ms. Dubman emphasized that the end users cannot see BRIDG directly and are generally not interested in the information architecture and associated diagrams; however, in the case of RegistryNXT!, the end users (site personnel/clinicians) love the ease of use of the resulting application that was built from BRIDG. This is as it should be, explained Ms. Dubman.
Isabelle de Zegher, Implementing a BRIDG-Based Canonical Data Model as the Core of System Integration: A Concrete Approach with Lessons Learned Isabelle de Zegher of Perceptive Informatics presented on Perceptive’s used of a BRIDG-based canonical model for their eClinical system, a set of tools that supports trials and consists of 20+ applications and 50+ integrations, most of which require configurations or programming for study set up.
Dr. de Zegher described the benefit of a BRIDG-based canonical data model as being similar to utilizing a shared language at a meeting between different nations. BRIDG provides this semantic interoperability as a common model across all domains of interest, with a robust datatype specification and vocabularies and value sets linked to concepts defined within the model that allows for a formal process for defining specific structures to be exchanged between machines, enabling a “data exchange standard.”
Dr. de Zegher stressed that BRIDG is not always intuitive, that if you should need to expand upon BRIDG you may need to check with BRIDG experts first. However, she noted that BRIDG as a canonical data model saved many hours to build consensus, and that as it is the industry standard, BRIDG can be used across organizations and is understood to be compliant with emerging FDA data exchange standards. She also emphasized that a canonical data model, while a major first step, is not enough for system integration, and that a master data management system is necessary to combine people, process and technology.
Dr. de Zegher commented that BRIDG is now stable and well-documented and that it has reached a level of maturity such that it is quite beneficial for the industry.
Joerg Dillert, Under the Umbrella of HL7 and BRIDG: Future of Data Integration between PV(E2B) and CDM
Joerg Dillert of Oracle was the final speaker during this Session. He presented on how BRIDG effects drug safety. Mr. Dillert began by describing current challenges in reporting adverse events from clinical trials, highlighting generic data mapping, unblinding, lack of a two-way solution, lab data and coding as major challenges at this time.
Mr. Dillert described differences between the International Conference on Harmonization’s (ICH) E2B (R2) and E2B (R3), the former of which was developed for expedited reporting of adverse event reports, mandatory in the European Union since 2005. R3, or Revision 3, has been developed to ensure that the standard more closely adheres to current pharmacovigilance practices. R3 is based upon the International Organization for Standardization’s (ISO) standard framework, with a clearly defined Individual Case Safety Report (ICSR) and message structure.
Mr. Dillert went on to discuss the connection between E2B (R3) and Health Level 7 (HL7), and their relationship with BRIDG, noting that the BRIDG 3.1 adverse event sub-domain supports the ICSR HL7 message (along with other AE standards).. Mr. Dillert emphasized that at the current time, there is not yet a BRIDG mapping for E2B (R3). Mr. Dillert offered two options in setting up and integrating BRIDG: a “Simple Middleware” (holds data in single systems) and a data warehouse approach (loads data into a single place). He described the advantages and disadvantages to both. While “Simple Middleware,” is an industry-proven message system and is flexible in that it allows integration of new and replacement of other systems, as well as having a single point of integration and no data move being necessary; there is also no centralized view on data, different structures in different systems, and a lack of message and event API for all system vendors. The data warehouse approach, while holding all relevant data available in a single storage space, allows for a singular place for validation checks and dictionaries, as well as offering the ability to simply extract data, has heavy loads and may not always have up-to-date data.
Mr. Dillert’s recommendation to these issues was to combine both approaches, allowing for a view over the data (calling it BRIDG in Clinical R&D) with BRIDG creating the view that was lacking in the other two approaches. The advantages of this are that it allows an ISO standardized view, you can easily view and extract data in any format (not just HL7) through a standardized model; he offered that this is a defined model for new and further software development.
“In PDUFA IV, FDA indicates they would like to have HL7 used for eSubmission transport by 2013. In PDUFA V, you will see different language. CDER is taking measures such that these messages that confuse the industry will not be put into the public before they are vetted throughout the FDA.”
This was a fascinating session and it is clear that the value of BRIDG in clinical research is finally being demonstrated and appreciated.
By Andrea Vadakin
CDISC, Manager of Public Relations